Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

The participants were randomized to use a night application of bilateral lower extremity splints (23 participants) or using the soft liners of the splints only (23 participants). One participant was excluded from the liner group as he failed to disclose a recent diabetes diagnosis.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

One of the participants in the liner group was excluded from the study at the beginning as he developed type-II diabetes. The total number of participants in the liner group was thus 22 at baseline.

Reporting Groups

Description

Splinting Application

Participants will be asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.

Splint Liner Application

The liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance.

Participant Flow for 3 periods

Period 1: Start of Study

Splinting Application

Splint Liner Application

STARTED

23
[1]

22
[2]

COMPLETED

23

22

NOT COMPLETED

0

0

[1]

minor comfort issues were reported within the first 2 weeks of the trial

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

LE Splints Group

Participants were asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.

Splint Liner Application

The liner or protective sheath from the Walkabout™ splint was applied to the LEs, with the structural frame of the splint removed by the researcher in advance.

The most recent CD4 cell counts were extracted from the medical record.

[2]

The most recent measured HIV viral load (log viral load) was extracted from the medical record. Measured in viral copies/ml on a logarithmic scale with 1.48 log/ml representing undetectable viral load levels for the viral load test conducted in our site (less than 50 copies/ml)

[3]

The number of years living with HIV was calculated by subtracting the year of diagnosis to the year of sutdy enrollment.

[4]

Neuropathic Pain Scale (NPS) score, where a score of "0" equates to "no pain" and "100" is the maximum neuropathic pain score possible. The scale score is computed by totaling all 10 pain sub-scales, each individually scored from 0-10.

[5]

Pittsburgh Sleep Quality Index (PSQI),this is a 0-21 score scale with 21/21 denoting maximum sleep disturbances. The PSQI is scored by adding all seven sub-scales, each with a maximum score of three. A score greater than 5/21 characterizes the individual as a "poor sleeper."

[6]

The average of 3 reaching trials are reported. One participant in the liner group had extreme reaching values (>3 standard deviation from the mean) and was excluded from the report (n=22). Longer distances in this test represent better volitional control of balance in the sagittal plane. Reaching distances >30 cm are considered to be within normal limits.

[7]

The 6 minute walk distance was collected on all participants. Longer walking distances represent decreased impact on function. Non-HIV cohorts typically are able to walk 400-600m in six-minutes.

For this test, the investigators asked the participants to stand next to a wall without shoes and with their feet positioned hip-width apart on the floor with one shoulder close to the wall. The participants were instructed "to reach as far forward as possible, without losing your balance, touching the wall or stepping and crossing the tile threshold on the floor". The average distance of three reaching attempts was recorded and used in the analysis.

Time Frame

week 3

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

The number of participants returning for the first follow-up. One participant in the liner group had baseline scores greater than 3 standard deviation difference from the mean and was excluded from the analysis.

Limitations of the study, such as early termination leading to small numbers of participants
analyzed and technical problems with measurement leading to unreliable or uninterpretable data

The contrast between the splinting group and liner group was statistically underpowered. The data was collected and analyzed by the primary investigator. The clinical diagnosis of peripheral neuropathy was not confirmed with EMG or punch skin biopsy.